search
Back to results

Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

Primary Purpose

Essential Thrombocythemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anagre Cap.
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Thrombocythemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with essential thrombocythemia according to WHO 2008

  • Any of the following as high-risk patient

    • Over 60 years old
    • >100 X 10^4/ul of platelet count
    • increased more than 300K of platelet count in 3 months
    • Hypertension, diabetes, past history of thromboembolic bleeding

Exclusion Criteria:

  • Patients with an adverse drug reaction or intolerability to anagrelide

  • Any of the following cardiac abnormalities;

    • Complete left bundle branch block on ECG
    • Patients using a pacemaker
    • Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome
    • Currently, there is no clinically uncontrolled ventricular or atrial tachycardia
    • Clinically significant bradycardia (<less than 50 per minute)
    • History of clinically proven myocardial infarction and unstable angina within 3 months
  • Pregnant women, nursing mothers

Sites / Locations

  • National Health Insurance Service Ilsan Hospital
  • The Catholic University of Korea. ST. Vincents Hospital
  • Hallym UNIV. Medical Center
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook national university hospital
  • Dongguk University Medical Center
  • Cheonnam National University Hwasun Hospital
  • Gachon University Gil Medical Center
  • Inha University Hospital
  • Jeju National University Hospital
  • Pusan National University Hospital
  • Ewha Wonans University Mokdong Hospital
  • Hallym UNIV. Medical Center
  • Inje University Sanggye Paik Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • SMG - SNU Boramae Medical Center
  • Soon Chun Hyang University Hospital Seoul
  • Veterans Health Service medical Center
  • Yonsei University Health System, SEVERANCE HOSPITAL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anagre Cap.

Arm Description

twice a day

Outcomes

Primary Outcome Measures

response rate for less than 60 X 10^4/ul in platelet count

Secondary Outcome Measures

response rate for less than 60 X 10^4/ul in platelet count
changes from baseline in 50% reduction rate in platelet count
response rate for less than 40 X 10^4/ul in platelet count
cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
incidence of adverse events

Full Information

First Posted
July 11, 2017
Last Updated
July 20, 2021
Sponsor
Yuhan Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03232177
Brief Title
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
Official Title
A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
December 5, 2020 (Actual)
Study Completion Date
December 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anagre Cap.
Arm Type
Experimental
Arm Description
twice a day
Intervention Type
Drug
Intervention Name(s)
Anagre Cap.
Intervention Description
from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
Primary Outcome Measure Information:
Title
response rate for less than 60 X 10^4/ul in platelet count
Time Frame
at week 8
Secondary Outcome Measure Information:
Title
response rate for less than 60 X 10^4/ul in platelet count
Time Frame
at week 52
Title
changes from baseline in 50% reduction rate in platelet count
Time Frame
up to 52 weeks
Title
response rate for less than 40 X 10^4/ul in platelet count
Time Frame
up to 52 weeks
Title
cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
Time Frame
at 52 week
Title
incidence of adverse events
Time Frame
up to 52 weeks
Other Pre-specified Outcome Measures:
Title
expression of MPN-oncogene(JAK2/CALR/MPL)
Description
association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations
Time Frame
at 52 week
Title
genomic biomarker search for prediction of side effects of anagrelide
Time Frame
at 52 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with essential thrombocythemia according to WHO 2008 Any of the following as high-risk patient Over 60 years old >100 X 10^4/ul of platelet count increased more than 300K of platelet count in 3 months Hypertension, diabetes, past history of thromboembolic bleeding Exclusion Criteria: Patients with an adverse drug reaction or intolerability to anagrelide Any of the following cardiac abnormalities; Complete left bundle branch block on ECG Patients using a pacemaker Patients with a family history of congenital QT prolongation syndrome or known QT prolongation syndrome Currently, there is no clinically uncontrolled ventricular or atrial tachycardia Clinically significant bradycardia (<less than 50 per minute) History of clinically proven myocardial infarction and unstable angina within 3 months Pregnant women, nursing mothers
Facility Information:
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
The Catholic University of Korea. ST. Vincents Hospital
City
Suwon-si
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Hallym UNIV. Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook national university hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Goyang
Country
Korea, Republic of
Facility Name
Cheonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju City
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Ewha Wonans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym UNIV. Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMG - SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
Veterans Health Service medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System, SEVERANCE HOSPITAL
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anagre Cap. in Patients With High-Risk Essential Thrombocythemia

We'll reach out to this number within 24 hrs